Details for New Drug Application (NDA): 021127

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NDA 021127 describes OPTIVAR, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. Additional details are available on the OPTIVAR profile page.

The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for 021127

Tradename:	OPTIVAR
Applicant:	Mylan Speciality Lp
Ingredient:	azelastine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Paragraph IV (Patent) Challenges for 021127

Tradename	Dosage	Ingredient	NDA	Submissiondate
OPTIVAR	SOLUTION/DROPS;OPHTHALMIC	azelastine hydrochloride	021127	2006-12-13

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	May 22, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021127

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	Start Trial	Start Trial
Mylan Speciality Lp	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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